Swab deliverable actives

ABSTRACT

A swab product is provided which includes a swab defined by an elongate stem and a fibrous absorbent covering such as cotton on at least one end of the stem. The fibrous absorbent covering is held together by a film-forming polymer. A treatment agent is provided which includes an active agent in a carrier. Particularly preferred is a highly viscous hydrophobic treatment composition such as petrolatum serving as a carrier for actives such as bacitracin ointment.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention concerns swabs impregnated with physiologically activeagents and a related method for topically treating skin, hair and theoral cavity.

2. The Related Art

Swabs having an absorbent covering on the tip and an elongated stem arewell known. Cotton is generally used as the absorbent covering material.Stem materials are often of wood, rolled paper or plastic. An adhesivebinder may be used to more firmly hold the absorbent covering in placeupon the swab. Ordinarily extremely small amounts of binder are used soas not to interfere with the billowy nature of the attached cotton.

Swabs have been used as applicators for a variety of cosmetic andpharmaceutical purposes. Rarely are they pretreated with any sort ofagent intended for transfer. It is up to the consumer to dip the swabinto a particular agent or cosmetic which they wish to apply to theirbody. Non-pretreatment of swabs has the advantage of universality andallows choice to the consumer. Unfortunately, universality sacrificesthe advantage of convenience. Perhaps even more important is sacrificeof the functional advantage from a swab engineered to solve a particularproblem.

U.S. Pat. No. 5,035,348 and U.S. Pat. No. 5,100,028, both to Seifert andassigned to the Institute Guilfoyle, disclose an engineered swab-typearticle intended for delivery of liquid products to the skin. Therein isdisclosed a flexible stick-like fluid dispenser mounted with a cottontip. A frangible seal separates the fluid compartment from the tip. Uponapplication of force against the seal, a separation wall breaks allowingfluid to permeate the cotton tip. Products related to this technologyare sold by the Purdue Frederick Company under the trademark Betadine®Prep Stick. This product is described as a self-saturating disposableswab applicator for povidone-iodine used as a topical antiseptic. TheBetadine® Prep Stick applicator is marketed as an individual swab sealedwithin a tear open pouch. Systems of this type are expensive tomanufacture, and somewhat messy considering the requirement for theactive agent to be delivered in a relatively non-viscous highly fluidcarrier. Active agents must also be soluble in that carrier for transferto the tip.

U.S. Pat. No. 5,846,215 and U.S. Pat. No. 5,919,152 to Zygmont disclosea swab whose absorbent covering has been treated for resistance tobacterial contamination. The covering, in particular a cotton wad, isdipped into a padding medium which includes an anti-microbial agentdispersed in a water slurry having up to 20% of a binder. The swab isdried after the padding step resulting in the anti-microbial agent beingdeposited in dry form onto the cotton wad.

A particular problem in transference of active agents occurs where thetransferred composition is a relatively viscous substance. Fibers of thecotton tend to adhere to the viscous composition causing clumps offibers to transfer with the composition onto the body. Not only isdeposition of fibers onto the skin aesthetically and functionallydispleasing, but transfer of the composition as a non-messy, accurateapplication is thereby hindered.

Accordingly, it is an object of the present invention to provide a swabpretreated with an active agent for topical application to the body.

Another object of the present invention is to provide a cotton swabpretreated with an active agent forming an applicator system that cancleanly deliver the agent without interference and transfer of anysubstantial amount of cotton from the applicator tip.

SUMMARY OF THE INVENTION

A swab product is provided which includes:

(i) an elongate stem with first and second ends opposite one another, afibrous absorbent covering surrounding at least one of the first andsecond ends, the covering being held together by a film-forming polymer;and

(ii) a treatment composition including an active agent, the compositionhaving a viscosity ranging from about 50 cps to about 5,000,000 cps.

In a more particular aspect of the present invention, there is provideda swab product including:

(i) an elongate stem with first and second ends opposite one another,fibrous cellulosic absorbent covering surrounding at least one of thefirst and second ends, the cotton being held together by a film-formingpolymer in an effective amount to prevent the fibrous covering fromunfurling during use; and

(ii) a treatment composition including from about 0.0000001 to about 20%by weight of the composition of an active agent and from about 80 toabout 99.9% by weight of a composition of a hydrophobic cosmeticallyacceptable carrier, the composition having a viscosity ranging fromabout 100,000 cps to about 3,500,000 cps.

Still further, there is provided a method for treating diseased orinjured skin by applying through aid of a swab, a treatment compositionincluding an effective amount of an active agent against the disease orinjury suspended in a cosmetically acceptable carrier, the compositionhaving a viscosity ranging from about 50 to about 5,000,000 cps, theswab including an elongate stem with first and second ends opposite oneanother, an absorbent covering such as cotton surrounding at least oneof the first and second ends, the covering being held together by afilm-forming polymer and whereupon is deposited the treatmentcomposition.

BRIEF DESCRIPTION OF THE DRAWING

Further objects, features and advantages of the present invention willbecome more readily apparent from consideration of the drawing whichconsists of a sole Figure showing in cross section a swab within aseated pouch.

BRIEF DESCRIPTION OF THE INVENTION

Now it has been found that fibrous absorbent coverings such as cotton orrayon can maintain their integrity by impregnation with a film-formingpolymer.

Furthermore, treatment compositions deposited on the fibrous coveringcan be transferred to a human body surface with less concern. Transferwill no longer be inhibited by the composition adhering more to thefibrous absorbent than to the body surface intended for treatment. Nolonger will any substantial amount of cotton separate from the coveringwad through binding more strongly to the transferred viscous treatmentcomposition.

The Figure illustrates a sealed pouch 2 with interior cavity 4 revealedto show a swab 6. Constituents of the swab include a stem 8 and afibered absorbent covering 10 at a first end of the stem. A treatmentcomposition 12 with a bacitracin ointment is delivered within anoleaginous carrier of mineral oil/petrolatum.

Stems of the present invention can be formed from natural and syntheticmaterials. Among the natural materials are cellulosics such as rolledpaper and wood. Suitable synthetic materials for the stems include avariety of plastics such as polystyrene, polypropylene, polyethylene,polyamides, polyester and polyvinyl chloride. Most preferred arepolystyrene, polypropylene and polyethylene. When the treatmentcomposition has a hydrophobic carrier such as mineral oil and/orpetrolatum, cellulosic or wood materials are not preferred becauseadhesives and other substances within the cellulosic tend to break downduring long periods of contact.

Fibered absorbent coverings may be derived from natural or syntheticfibers. Cellulosics are the preferred natural fibered absorbent. Cotton,rayon and mixtures thereof are most preferred. Other types of fiberedwads may also be employed. Particularly useful are Fiberedpolypropylene, polyethylene, polyester and polyamide.

Film-forming polymers of the present invention may be selected fromnonionic, anionic, cationic and amphoteric polymers.

Examples of nonionic polymers suitable for film-forming purposes are thecopolymers of vinyl acetate and crotonic acid, terpolymers of vinylacetate, crotonic acid and a vinyl ester of an alpha-branched saturatedaliphatic monocarboxylic acid such as vinyl neodecanoate; copolymers ofmethyl vinyl ether and maleic anhydride (molar ratio about 1:1) whereinsuch copolymers are 50% esterified with a saturated alcohol containingfrom 1 to 4 carbon atoms such as ethanol or butanol; and acrylicpolymers containing acrylic acid or methacrylic acid or their esterswith one or more saturated alcohols having from 1 to 22 carbon atomssuch as methyl methacrylate, ethyl acrylate, ethyl methacrylate, n-butylmethacrylate, n-hexyl acrylate, n-octyl acrylate, lauryl methacrylateand behenyl acrylate, glycols having from 1 to 6 carbon atoms such ashydroxypropyl methacrylate and hydroxyethyl acrylate, styrene, vinylcaprolactam, vinyl acetate, acrylamide, alkyl acrylamides andmethacrylamides having 1 to 8 carbon atoms in the alkyl group such asmethacrylamide, t-butyl acrylamide and n-octyl acrylamide, and othercompatible unsaturated monomers. One specific example is the emulsionpolymerized terpolymer of methacrylic acid, n-butyl acrylate and ethylacrylate (e.g., in a weight percent ratio of 31:42:27, respectively).

Further examples of nonionic film-forming polymers are homopolymers ofN-vinylpyrrolidone and copolymers of N-vinylpyrrolidone with compatiblenonionic monomers such as vinyl acetate and terpolymers of ethylacrylate, butyl methacrylate and methyl methacrylate. Nonionic polymerscontaining N-vinylpyrrolidone in various weight average molecularweights are available commercially from ISP Corporation such ashomopolymers of N-vinylpyrrolidone having an average molecular weight ofabout 630,000 under the trademark PVP K-90 and those having an averagemolecular weight of about 1,000,000 sold under the trademark of PVPK-120. Particularly preferred is poly(methyl vinyl ethertmaleicanhydride) as an unneutralized resin available from ISP Corporationunder the trademark Gantrez® S-97 BF.

Anionic film-forming polymers often are derived from the nonionic typeswhich include carboxylic acid functions. Alkaline agents are employed toneutralize the carboxylic acid or anhydride transforming them intoanionic salts. Examples of suitable neutralizing agents include2-amino-2-methyl-1,3-propanediol (AMPD); 2-amino-2-ethyl-1,3-propanediol(AEPD); 2-amino-2-methyl-1-propanol (AMP); 2-amino-1-butanol (AB);monoethanolamine (MEA); diethanolamine (DEA); triethanolamine (TEA);monoisopropanolamine (MIPA); diisopropanol-amine (DIPA);triisopropanolamine (TIPA); and dimethyl stearamine (DMS). Mostpreferred is AMP.

Particularly preferred anionic polymers are the salts of poly(methylvinyl ether/maleic anhydride) and polystyrene sulfonic acid. The formeris obtained by at least partial neutralization of Gantrez® S-97 BF andthe latter available from the National Starch & Chemical Company underthe trademarks Versa TL-501 and Flexan® 130 having respective molecularweights of about 500,000 and 100,000. Other polymer films which may beemployed and are commercially available are listed in the Table below.

TABLE I POLYMER TRADEMARKS (SUPPLIER) CTFA DESINGATIONS Resyn ® 28-1310(NSC) Vinyl acetate/crotonic acid copolymer Resyn ® 28-2930 (NSC) Vinylacetate/crotonic acid/vinyl neodecanoate copolymer Resyn ® 28-2913 (NSC)Vinyl acetate/crotonic acid/vinyl neodecanoate copolymer Versatyl ® 40(NSC) Octylacrylamide/acrylates copolymer Versatyl ® 42 (NSC)Octylacrylamide/acrylates copolymer Experimental Resin (NSC) Vinylacetate/vinyl neodecanoate/maleic half-ester Ultrahold-8 ® (BASF)Acrylate/acrylamide copolymer Luviset ® CAP (BASF) Vinylacetate/crotonic acid/vinyl propionate copolymer PVP K-30 (ISP) PVPPVP/VA E-335 (ISP) PVP/Vinyl acetate copolymer PVP/VA E-735 (ISP)PVP/Vinyl acetate copolymer Gantrez ® ES-225 (ISP) Ethyl ester of PVM/MAcopolymer Gantrez ® ES-425 (ISP) Butyl ester of PVM/MA copolymerGaffix ® VC-713 (ISP) Aminoethyl methacrylate copolymer

Cationic amphoteric film-forming polymers suitable for the presentinvention may be prepared as homo- or copolymers from monomersincluding:

Dimethyl aminoethyl acrylate (DMAEA), Dimethylaminoethyl methacrylate(DMAEMA), Dimethylamino-propylacrylamide (DMAPAAm), andDimethylaminopropyl methacrylamide (DMAPMAAm) which are all(meth)acrylamides or (meth)acrylic acid esters having a diallkylaminogroup;

Dimethylaminostyrene (DMASt) and Dimethyaminomethylstyrene (DMAMSt) andthe like which are styrenes having a dialkylamino group;

4-Vinyl pyridine and 2-vinyl pyridine which are vinyl pyridines; and

Quaternized products of these with a known quatemizing agent such asalkyl halide, benzyl halide, alkyl or aryl sulfonic acid, or dialkylsulfate.

Among suitable film-forming polymers are those derived from monomerssuch as:

N-(3-sulfopropyl)-N-acryloyloxyethyl-N,N-dimethylammonium betaine,N-(3-sulfopropyl)-N-methacroylamidepropyl-N ,N-dimethylammonium betaine,N-(3-carboxymethyl)-N-methacroylamidepropyl-N, N-dimethylammoniumbetaine and N-carboxymethyl-N-methacroyloxyethyl-N,N-dimethylammoniumbetaine.

The most preferred polymers for use in the present invention arechemically modified cellulosics, especially methyl cellulose,hydroxypropyl methylcellulose, methyl cellulose, ethyl cellulose,hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodiumcarboxymethyl cellulose and combinations thereof available under theMethocel® brand from the Dow Chemical Company.

Amounts of the film-forming polymer may range from about 0.0001 to about10%, preferably from about 0.01 to about 5%, more preferably from about0.1 to about 3%, optimally from about 0.25 to about 0.75% by weight ofthe absorbent covering.

The treatment composition relative to the fibrous absorbent coveringwill have a weight ratio ranging from about 100:1 to about 1:100,preferably from about 20:1 to about 1:20 by weight.

Optionally, active agents may be included within the treatmentcompositions. Suitable active agents for the present invention includeanti-microbial agents, anti-inflammatory agents, antiseptic agents,anaesthetic agents, anti-acne agents, anti-irritant agents andcombinations thereof.

Illustrative anti-microbial agents (antibacterial, anti-fungal,anti-protozoal and antiviral) are beta-lactams, quinolones,ciprofloxacin, norfloxacin, tetracycline, erythromycin, amikacin,doxycycline, capreomycin, chlorhexidine, chlortetracycline,oxytetracycline, clindamycine, ethambutol, metronidazole, pentamidine,gentamicin, kanamycin, lineomycin, methacycline, methenamine,minocycline, neomycin, netilmicin, paromomycin, streptomycin,tobramycin, miconazole, amanfadine, clindamycin and cephalosporin.Anti-microbial agents preferred for inclusion in compositions of thepresent invention include tetracycline hydrochloride, erythromycinestolate, erythromycin stearate (salt), amikacin sulfate, doxycyclinehydrochloride, capreomycin sulfate, chlorhexidine gluconate,chlorhexidine hydrochloride, chlortetracycline hydrochloride,oxytetracycline hydrochloride, clindamycin hydrochloride, ethambutolhydrochloride, metronidazole hydrochloride, penamidine hydrochloride,gentamicin sulfate, kamaycin sulfate, lineomycin hydrochloride,methacryline hydrochloride, methenamine hippurate, methenaminemandelate, minocycline hydrochloride, neomycin sulfate, netilmicinsulfate, paromomycin sulfate, streptomycin sulfate, tobramycin sulfate,miconazole hydrochloride, amanfadine hydrochloride, amanfadine sulfate,triclosan, octopirox, p-chloro-m-xylenol, nystatin, tolnafate andclotrimazole. Most preferred are polymyxin B sulfate, neomycin andbacitracin (particularly zinc bacitracin).

Illustrative anti-inflammatory agents are aspirin, acetaminophen,ibuprofen, naproxen, benoxaprofen, flurbiprofen, fenoprofen, fenbufen,ketoprofen, indoprofen, pirprofen, carprofen, oxaprozin, pranoprofen,miroprofen, tioxaprofen, suprofen, alminoprofen, tiaprofenic acid,fluprofen and bucloxic acid. Also useful are the steroidalanti-inflammatory agents including hydrocortisone.

Antiseptic agents suitable for the present include phenoxyisopropanol,resorcinol, chlorhexidine, hydrogen peroxide, organic C₂-C₃₀ peroxides,povidone and iodine.

Anaesthetic agents suitable for the present invention includebenzocaine, lidocaine, bupivacaine, chlorprocaine, dibucaine,etidocaine, mepivacaine, tetracaine, dyclonine, hexylcaine, procaine,cocaine, ketamine, pramoxine, phenol and pharmaceutically acceptablesalts thereof.

Anti-acne agents include alpha-hydroxy carboxylic acids (e.g. glycolicacid, lactic acid and gluconolactone), beta-hydroxy carboxylic acids(e.g. salicylic acid), benzoyl peroxide, sulfur, retinoids (e.g. retinoland retinoic acid) and combinations thereof.

Anti-irritant agents suitable for the present invention includealpha-bisabolol, farnesol, chamomile extract, phytic acid, andglycyrrhetinic acid and salts thereof.

Amounts of the active agents will depend on their activity. Generally,amounts of any active may range from about 0.0000001 to about 20%,preferably from about 0.000001 to about 10%, more preferably from about0.00001 to about 5%, particularly preferably from about 0.01 to about1%, even more preferably from about 0.1 to about 0.5% by weight of thetreatment composition.

A pharmaceutically or cosmetically acceptable carrier will also benecessary for delivery of the active agent. Carriers may either behydrophilic or hydrophobic, although the latter are much preferred.

Typical hydrophilic carriers include polyhydric alcohols andpolyalkoxylated ethers and esters.

Representative of polyhydric alcohols are glycerin, propylene glycol,dipropylene glycol, polypropylene glycol, polyethylene glycol, sorbitol,hydroxypropyl sorbitol, hexylene glycol, 1,3-butylene glycol,1,2,6-hexanetriol, fructose, mannose and combinations thereof.

Representative polyalkoxylated ethers and esters include ethoxylatedglycerin, propoxylated glycerin, ethylene glycol mono- and di- C₈-C₂₂fatty acid esters, polyethylene glycol mono- and di- C₈-C₂₂ fatty acidesters, polypropylene glycol mono- and di- C₈-C₂₂ fatty acid esters,glyceryl mono- and di- C₈-C₂₂ fatty acid esters, ethoxylated glycerylmonostearate, butylene glycol distearate, sorbitan C₈-C₂₂ fatty acidesters, polyoxyethylene sorbitan C₈-C₂₂ fatty acid esters andcombinations thereof.

Hydrophobic carriers include silicone oils/gums; hydrocarbons; fattyalcohols; mono-, di and tri-glycerides; and fatty acids and estersthereof including waxes.

Among the preferred silicones are polyalkyl siloxanes, polyalkylarylsiloxanes, polyether siloxane copolymers and combinations thereof.Average number molecular weights may range from about 100 to about5,000,000. The silicones may be grafted and/or crosslinked. The lattermay form silicone elastomers such as Polysilicone-11.

Hydrocarbons include mineral oil, isoparaffin, petrolatum, paraffin wax,polyalphaolefin, squalane and squalene, polybutene, microcrystallinepolyethylene wax and combinations thereof.

Representative esters include C₂-C₄₀ alkenyl or alkyl esters of fattyacids. Examples include isoarachidyl neopentanoate, isononyl isonanoate,oleyl myristate, oleyl stearate, oleyl oleate and combinations thereof.Wax esters may also be included such as beeswax, spermaceti andarachidyl behenate. Sterol esters are suitable including cholesterolfatty acid esters.

Fatty acids and fatty alcohols, each having from 8 to 30 carbon atomsmay be included as a hydrophobic pharmaceutically acceptable carrier.Representative of the fatty acids are lauric, myristic, palmitic andstearic acids. Representative of the fatty alcohols are lauryl,palmityl, stearyl, isostearyl and cetearyl alcohols.

Amounts of any of the carriers may range from about 1 to about 99.9%,preferably from about 80 to about 99.9%, optimally from about 95 toabout 99% by weight of the treatment composition.

Viscosity of the treatment composition should range from about 50 cps toabout 5 million cps, preferably from about 100,000 to about 3,500,000cps, more preferably from about 800,000 to about 2,500,000 cps,optimally from about 1,000,000 to about 2,000,000 cps, as measured witha Brookfield DV-1+ Viscometer at 25° C. using a TF Spindle rotating at 5rpm. This measurement is via descending heliopath for one minute, usinga factor of 20,000 to convert to cps units.

Swabs of the present invention are preferably loaded with a hydrophobicoleaginous treatment composition. More particularly, the oleaginoustreatment composition utilizes a carrier combination of mineral oil andpetrolatum. Anti-microbial agents such as bacitracin are supportedwithin the oleaginous treatment composition. The resultant thickcarrier/active system is deposited onto the cotton absorbent covering atthe end of a plastic stick. The combination is then placed within alaminated foil pouch with the perimeter sealed to prevent anycontamination of the contents. When needed, the sealed pouch can bebroken (most easily at a tear arrow along a line of package weakness)and the ointment treated cotton tip applied to an open wound as firstaid treatment against infection.

Except where otherwise explicitly indicated, all numbers in thisdescription indicating amounts of material ought to be understood asmodified by the word “about”. All parts, percentages and proportionsreferred to herein and in the appended claims are by weight unlessotherwise indicated.

The term “comprising” is meant not to be limiting to any subsequentlystated elements but rather to encompass non-specified elements of majoror minor functional importance. In other words the listed steps,elements or options need not be exhaustive.

The foregoing description illustrates selected embodiments of thepresent invention. In light thereof variations and modifications will besuggested to one skilled in the art, all of which are within the spiritand purview of this invention.

What is claimed is:
 1. A swab product comprising: (i) an elongate stemwith first and second ends opposite one another, a fibrous absorbentcovering surrounding at least one of the first and second ends, thecovering being impregnated with and held together by a film-formingpolymer; and (ii) a treatment composition comprising an active agent andfrom about 80 to about 99.9% of a hydrophobic carrier, the compositiondeposited onto the film-forming polymer impregnated covering and havinga viscosity ranging from about 50 cps to about 5,000,000 cps.
 2. Theproduct according to claim 1 wherein the-carrier is selected from thegroup consisting of mineral oil, petrolatum, paraffin wax, isoparaffin,potyalphaolefin, polybutene, microcrystalline polyethylene wax andcombinations thereof.
 3. The product according to claim 1 wherein theabsorbent covering comprises cotton.
 4. The product according to claim 1wherein the film-forming polymer is a chemically modified cellulosepolymer.
 5. The product according to claim 4 wherein the chemicallymodified cellulose polymer is selected from the group consisting ofmethyl cellulose, ethyl cellulose, hydroxypropyl cellulose,hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose andcombinations thereof.
 6. The product according to claim 1 wherein theactive agent is selected from the group consisting of anti-microbialagents, anti-inflammatory agents, antiseptic agents, anaesthetic agents,anti-acne agents, anti-irritant agents and combinations thereof.
 7. Theproduct according to claim 1 wherein the treatment composition has aviscosity ranging from about 800,000 cps to about 2,500,000 cps.
 8. Aswab product comprising: (i) an elongate stem with first and second endsopposite one another, a fibrous cellulosic absorbent coveringsurrounding at least one of the first and second ends, the coveringbeing held together by a film-forming polymer in an amount from about0.0001 to about 10% by weight of the covering; and (ii) a treatmentcomposition comprising from about 0.0000001 to about 20% by weight ofthe composition of an active agent and from about 80 to about 99.9% byweight of the composition of a cosmetically acceptable carrier, thecomposition having a viscosity ranging from about 100,000 to about3,500,000 cps.
 9. A method for treating diseased or injured skincomprising applying to the skin through aid of a swab a treatmentcomposition via a swab product comprising: (i) an elongate stem withfirst and second ends opposite one another, a fibrous absorbent coveringsurrounding at least one of the first and second ends, the coveringbeing impregnated with and held together by a film-forming polymer in aneffective amount to prevent the covering from unfurling during use; and(ii) a treatment composition comprising an active agent dispersed infrom about 80 to about 99.9% of a hydrophobic carrier, the compositiondeposited onto the film-forming polymer impregnated covering and havinga viscosity ranging from about 100,000 cps to about 5,000,000 cps.